Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma

To confirm and extend these findings, we report one of the coprimary end points of a randomized, double-blind, multicenter, phase 3 trial that was conducted to evaluate the safety and efficacy of nivolumab alone or nivolumab combined with ipilimumab in comparison with ipilimumab alone in patients with previously untreated metastatic melanoma

James Larkin

2015

Scholarcy highlights

  • Nivolumab and ipilimumab have been shown to have complementary activity in metastatic melanoma
  • In patients with PD-L1–negative tumors, the combination of PD-1 and cytotoxic T-lymphocyte–associated antigen 4 blockade was more effective than either agent alone.
  • Ipilimumab, an anti–cytotoxic T-lymphocyte–associated antigen 4 antibody, acts to up-regulate antitumor immunity and was the first agent to be associated with an improvement in overall survival in a phase 3 study involving patients with metastatic melanoma
  • Other eligibility criteria included an age of at least 18 years; an Eastern Cooperative Oncology Group performance-status score of 0, indicating no symptoms, or 1, indicating mild symptoms; measurable disease as assessed by means of computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors, version 1.115; availability of tissue collected from metastatic or unresectable tumors for the assessment of PD-L1 status; and known BRAF V600 mutation status
  • A total of 945 patients underwent randomization: 316 patients were assigned to the nivolumab group, to the nivolumab-plusipilimumab group, and to the ipilimumab group
  • The hazard ratio for the comparison between the nivolumab-plus-ipilimumab group and the nivolumab group was 0.74
  • The characteristics of the study participants at baseline were typical of patients with advanced melanoma, the proportion of patients with BRAF mutation was lower than the 40 to 50% that is generally reported for patients with advanced disease
  • Considerable progress in the treatment of metastatic melanoma has been made in the past 5 years, with the approval of immune checkpoint–blocking antibodies and, in parallel, agents targeting aberrant signaling in the 40 to 50% of melanomas with BRAF mutations. Ipilimumab, an anti–cytotoxic T-lymphocyte–associated antigen 4 antibody, acts to up-regulate antitumor immunity and was the first agent to be associated with an improvement in overall survival in a phase 3 study involving patients with metastatic melanoma. Ipilimumab was associated with responses in 10% and 15% of patients; approximately 20% of treated patients had long-term survival

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